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A Phase I Study of the Oral Platinum Agent Satraplatin in Combination With Weekly Docetaxel

Phase 1
18 Years
Not Enrolling
Tumors, Prostate Cancer

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Trial Information

A Phase I Study of the Oral Platinum Agent Satraplatin in Combination With Weekly Docetaxel


Satraplatin is an oral platinum analog that is currently being evaluated in combination with
prednisone in a phase III clinical trial in patients with HRPC who have progressed following
one prior chemotherapy regimen.

Docetaxel is a taxane that is indicated for the treatment of patients with non-small cell
lung, breast, and prostate cancers. Specifically, it was recently approved in combination
with prednisone for the treatment of patients with hormone refractory prostate cancer
(HRPC). Docetaxel administered every 3 weeks was associated with a survival advantage versus
mitoxantrone. Docetaxel administered weekly showed an improvement in survival versus
mitoxantrone that was not statistically significant. However, it was better tolerated than
docetaxel administered every 3 weeks, with significantly less grade 3 and 4 toxicities,
especially neutropenia. The combination of satraplatin and weekly docetaxel may be a
feasible regimen for patients with chemotherapy-naïve HRPC and for patients with other
malignancies for which these medications show activity.


The objective of this study is to determine the optimum doses for satraplatin and weekly
docetaxel when the 2 drugs are given in combination.

Inclusion Criteria:

- Histologically proven advanced solid tumors.

- 2 prior chemotherapy regimens.

- Age greater than or equal to 18 years.

- Eastern Cooperative Oncology Group performance status 0-1.

- Life expectancy greater than 3 months.

- At least 4 weeks between prior surgery or radiotherapy and enrollment.

- Adequate organ function as defined by the following criteria (must be obtained within
1 week of the first day of treatment):

Absolute neutrophil count ≥ 1500/µL. Hemoglobin ≥ 10.0 g/dl. Platelets ≥ 100,000/µL. Serum
creatinine ≤ 1.5 upper limit of normal (ULN). Serum bilirubin ≤ ULN. AST/ALT ≤ 1.5 x the

- Patients must be able to swallow capsules.

- Patients must give written informed consent before study participation.

- No history of another cancer within the past 5 years (except basal or squamous cell
carcinoma of the skin).

- No brain or leptomeningeal metastases.

- Female patients must not be pregnant or lactating and must be willing to practice
contraception. Males must agree to contraceptive practices.

For HRPC cohort

- Patient must continue to be administered an LHRH agonist if they were receiving it at
the time of screening for entry onto this protocol. Patients who have undergone
bilateral orchiectomy do not need to be on LHRH agonists.

- Patient must be off of anti-androgen medications for ≥ 6 weeks.

- Patient must have castrate level of testosterone (< 50 ng/dL).

- Progressive HRPC as defined by one of the following:

- Rising PSA

- Sequential imaging studies

- Clinical suspicion in the view of the treating physician

Exclusion Criteria:

- Patients who are unwilling to use contraception.

- Patients with a history of major gastrointestinal surgery.

- Pre-existing peripheral neuropathy > grade 1.

- Pre-existing edema > grade 1.

- Patients with hearing loss or tinnitus > grade 2.

- Prior RT to >25% of the bone marrow.

- Concomitant use of medications that inhibit cytochrome P450 3A4 (including

- Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy
considered investigational (utilized for non-FDA - approved indications and in the
context of a research investigation).

- Patients who have not recovered (≥ grade 1) from the following toxicities of previous
regimens before enrollment:

- hematologic toxicities (parameters defined in protocol

- fatigue

- mucositis

- nausea/vomiting/diarrhea.

- Uncontrolled intercurrent illness including, but not limited to, ongoing active
infection, uncontrolled congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness that would limit compliance with study

- History of HIV or AIDS related illness.

- History of severe hypersensitivity reaction to docetaxel, polysorbate, or other drugs
formulated with polysorbate 80.

- Evidence of concurrent second malignancy.

- History of bone marrow or major organ transplant.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the maximum tolerated dose (MTD) of satraplatin administered every 4 weeks in combination with docetaxel administered weekly (3 of 4 weeks)

Outcome Time Frame:

30 days

Safety Issue:


Principal Investigator

Michael Petrone, MD

Investigator Role:

Study Director

Investigator Affiliation:

GPC Biotech Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

March 2006

Completion Date:

March 2009

Related Keywords:

  • Tumors
  • Prostate Cancer
  • Prostatic Neoplasms



Sarah Cannon Research Institute Nashville, Tennessee  37203